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Pericardial Resection to Treat Heart Failure

The Effects of Pericardiotomy on Diastolic Reserve in Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03073668
Enrollment
23
Registered
2017-03-08
Start date
2017-03-20
Completion date
2019-02-02
Last updated
2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

The researchers are doing this study to find out whether there will be less increase in cardiac filling pressure after the surgeon opens the pericardium (the membrane around the heart) than when the pericardium is intact. The researchers want to see whether opening the pericardium is an effective way to reduce the blood filling pressures in the heart.

Detailed description

This study will enroll patients with risk factors for LV diastolic dysfunction, either coronary artery disease or aortic stenosis, who are already undergoing cardiac surgery for clinical purposes (e.g. coronary artery bypass grafting or valvular heart disease). Hemodynamic tests will be performed using standard clinical resources used as part of routine care in this setting, including pulmonary artery (PA) catheterization. After obtaining written informed consent, patients will undergo induction with general anesthesia as per clinical practice. The chest will be open but pericardium left intact. Cardiac hemodynamics (PA wedge pressure, PAWP; PA pressure, PAP, right atrial pressure, RAP) will be measured using PA catheter already in place at rest, and then during conditions of increased cardiac preload, induced by passive leg elevation and saline bolus (300 ml administered over 1-2 minutes). The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint similar to our percutaneous approach but using currently-available surgical tools. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure (standard care). The surgical team will then repeat hemodynamic assessments at rest and with acute volume loading (leg raise + saline) in exactly the same manner as with the pericardium intact. Our hypothesis is that as compared to pericardium intact, the increase in PAWP with volume loading will be reduced following opening of the pericardium.

Interventions

PROCEDUREAnterior pericardiotomy

The surgical team will perform anterior pericardiotomy. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure.

DRUGSaline

During the measurement of cardiac hemodynamic tests, a saline bolus of 300 ml will be administered over 1-2 minutes.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion * \>17 years old * Subjects having open sternotomy for either aortic valve stenosis or coronary artery bypass grafting (or both) * Provide informed consent Exclusion * \<18 years old

Design outcomes

Primary

MeasureTime frameDescription
Change in Pulmonary Artery Wedge Pressure (PAWP)Baseline, approximately 1 hourPatients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.

Secondary

MeasureTime frameDescription
Change in Pulmonary Artery Pressure (PAP)Baseline, approximately 1 hourPatients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.
Change in Right Arterial Pressure (RAP)Baseline, approximately 1 hourPatients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026